- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955665
Reattachment of the SPR Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation
July 8, 2021 updated by: Peking University Third Hospital
The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation
Clinical outcomes between reattachment of the superior peroneal retinaculum (SPR) and the bone block procedure were compared in this study to elucidate which procedure was safer and more effective.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
From 2012 to 2016, 25 patients with recurrent peroneal tendon dislocation underwent the bone block procedure(group A), and another 22 patients underwent reattachment of the SPR (group B).
American Orthopaedic Foot and Ankle society (AOFAS) ankle-hindfoot score, Ankle Activity Score (AAS), time to return to sports activity, rate of return to sports level, range of motion (ROM) of the ankle, rate of recurrence, and overall patient satisfaction were collected to evaluate outcomes between the two groups.
Study Type
Observational
Enrollment (Actual)
47
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A consecutive series of patients with recurrent peroneal tendon dislocation who underwent operative treatment between 2012 and 2016 were retrieved.
Twenty-five patients underwent bone block procedure (group A), and 22 patients underwent reattachment of the SPR (group B)."
Description
Inclusion Criteria:
- a traumatic recurrent peroneal tendon dislocation requiring surgery
- a lack of response to at least 3 months of conservative treatment
Exclusion Criteria:
- the presence of an acute peroneal tendon dislocation
- a concomitant anterior talofibular ligament rupture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bone block procedure
patients with recurrent peroneal tendon dislocation underwent the bone block procedure
|
a 20 × 15 × 3 mm3 bone block was cut from the lateral malleolus, rotated backwards 45°, and sutured back to the periosteum of the lateral malleolus using non-absorbable sutures.
|
|
Reattachment of the superior peroneal retinaculum
patients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum
|
two suture anchors (Mini Quickanchor,DePuy Mitek) were inserted into the postero-lateral ridge of the lateral malleolus without damaging the cartilaginous ridge, after which the SPR was reattached to the lateral malleolus with the anchored suture.
The inner layer of the false pouch was incised, and the outer layer (periosteum) was sutured with the SPR in a pants-over-vest style.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AOFAS
Time Frame: 2 years after operation
|
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot).
The scale includes nine items that can be divided into three subscales (pain, function and alignment).
The minimum and maximum values of AOFAS are 100 and 0, respectively.
And higher scores mean a better outcome.
|
2 years after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: 2 years after operation
|
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints.
Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced.
This gives them the greatest freedom to choose their pain's exact intensity.
It also gives the maximum opportunity for each respondent to express a personal response style.
The minimum and maximum values of VAS are 10 and 0, respectively.
And higher scores mean a worse outcome.
|
2 years after operation
|
|
time to return to sports activity
Time Frame: up to 2 years
|
time to return to sports activity after surgery at each group
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Qinwei Guo, MD, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2012
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 9, 2021
Study Record Updates
Last Update Posted (Actual)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2018225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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